Embolic filter device and method of use thereof

ABSTRACT

In general, the invention features an intra-vascular device for filtering or deflecting emboli or other large objects from entering a protected secondary vessel or vessels. The device of the invention may include a filter, an central member, additional supporting members, and a delivery cable and may serve to filter or deflect emboli or other large objects from entering protected secondary vessels. The device may be capable of collapse along its longitudinal axis for ease of delivery to the treatment site. The device may further be compatible with common delivery methods used in interventional cardiology (e.g., TAVI procedures). The device may be integrated into the delivery systems. In other embodiments the device may be detachable from the delivery system. Upon deployment, the device may be positioned so as to contact the orifice of one or more secondary blood vessels. Upon retrieval the device may be retracted in an orientation substantially similar to the original deployment orientation.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims benefit of U.S. Provisional Application No.61/490,156, which is hereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to devices for blocking emboli in an aorta fromentering arteries.

BACKGROUND OF THE INVENTION

Devices such as vascular filters or other devices may be inserted into ablood vessel prior to or during a procedure or at another time. Suchdevices may be inserted by way of a catheter that may be threadedthrough a vein or artery and into, for example, an aorta or other vesselwhere the device may be released from the catheter and, for example,deployed. The device may filter, deflect, or block emboli or otherobjects from entering into a blood supply that feeds the brain.

SUMMARY OF THE INVENTION

In one aspect, the invention features an intra-vascular device fordeflecting emboli including a substantially planar filter (e.g., afilter made from Nitinol mesh or perforated film) and a central memberconnected to the filter. The device can be configured such that, whendeployed in a primary blood vessel, the central member partiallyobstructs one or more secondary blood vessels, and a portion of thecentral member extends from a horizontal plane of the filter into asecondary blood vessel. The device can be, when deployed in a primaryblood vessel, capable of collapse along a longitudinal axis.

In the devices of the invention, the central member can be hollow. Thecentral member can be capable of providing structural support and canfurther be capable of permitting the passage of a guidewire.

Any of the devices of the invention can include one or more additionalmembers extending outwards from the central member. These additionalmembers can be capable of providing structural support. These additionalmembers can also be cylindrical and/or hollow. These additional membersand/or the central member can include NiTi.

In any of the devices of the invention, the filter material can includebraided, woven, or clustered material. In certain aspects, the filtercan include laminated mesh. For example, the mesh can include polymericfilm, e.g., perforated polymeric film.

The substantially planar filter can be adapted to conform to the vesselwall. In other aspects, the filter can include an outer skeleton. Theouter skeleton can be capable of defining the edge of the substantiallyplanar filter, or the filter material can extend beyond the outerskeleton, e.g., allowing the filter to conform to the vessel wall. Inother aspects, the outer skeleton can be capable of controlling contactwith the vessel wall.

In any of the devices of the invention, the filter can include DrawnFilled Tubing, e.g., including an outer layer of Nitinol and/or a corethat includes tantalum and/or platinum.

In any of the devices of the invention, the device can further include aradiopacity marker (e.g., a bead or a clamp).

In yet other aspects, any device of the invention can include additionalmembers that are located above and/or below the filter.

In any of the devices of the invention, the central member may alsoinclude a preformed bend. The preformed bend can be between 5° and 90°.In some aspects, the device also includes a second filter attached tothe central member portion proximal to the first filter (and also, e.g.,proximal to the preformed bend). The second filter can be sized tofilter a secondary blood vessel. In other aspects, the central membercan pass through the second filter. The second filter can have thecapability of preventing particles from passing from the primary bloodvessel to the secondary blood vessel.

In any of the devices of the invention, the substantially planar filtercan further include a length to width ratio between 8:1 and 18:7. Inother aspects, the central member can, e.g., pass through the filterand/or be connected to a delivery cable. In any of the devices of theinvention, the device can have the capability of enclosure within anexternal sheath prior to deployment.

In another aspect, the invention features a method of preventing passageof a particle from the aorta into the left subclavian, left commoncarotid, or brachiocephalic artery including: inserting a guidewirethrough one of the left subclavian, left common carotid, orbrachiocephalic artery and into the aortic arch; passing a cathetercontaining the device of any of the above devices in collapsed form overthe guidewire and into the aortic arch; and retracting the catheter sothat said device is deployed in the aortic arch, thereby preventingpassage of a particle from the aorta into the left subclavian, leftcommon carotid, or brachiocephalic artery.

In another aspect, the invention features a method of preventing passageof a particle from the aorta into the left subclavian, left commoncarotid, or brachiocephalic artery by inserting into the aorta any ofthe above-described devices such that the device prevents a particlefrom passing to the left subclavian, left common carotid, andbrachiocephalic artery.

In any of the above methods, the device can be retrieved in anorientation substantially similar to the deployment orientation. Also,the secondary filter can prevent passage of particles into thebrachiocephalic artery. The connection between the device and a deliverycable can be constant throughout insertion, deployment, and retrieval,and the devices can be enclosed within an external sheath prior todeployment.

As used herein, the term “central member” refers to a structural elementwithin the perimeter of the filter that improves structural propertiesand facilitates insertion, deployment, and retrieval of the device.

As used herein, the term “substantially flat” refers to a radius ofcurvature of no more than 80 mm (e.g., 10 mm, 20 mm, 30 mm, 40 mm, 50mm, 60 mm, or 70 mm).

As used herein, the term “blood” refers to all or any of the following:red cells (erythrocytes), white cells (leukocytes), platelets(thrombocytes), and plasma.

As used herein, the term “delivery cable” refers to any delivery systemused in interventional cardiology to introduce foreign bodies to atreatment site (e.g., catheters, guidewires, tubes, and wires).

As used herein, the term “provide structural support” refers to theproperty contributing to shape and stiffness of the device.

As used herein, the term “wires” refers to any elongated structure(e.g., cords, fibers, yarns, filaments, cables, and threads) fabricatedfrom any non-degradable material (e.g., polycarbonate,polytetrafluorothylene (PTFE), expanded polytetrafluorothylene (ePTFE),polyvinylidene fluoride, (PVDF), polypropylene, porous urethane,Nitinol, fluropolymers (Teflon®), cobalt chromium alloys (CoCr), andpara-aramid (Kevlar®), or textile (e.g., nylon, polyester (Dacron®), orsilk).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of the guidewire (10) passed through theleft subclavian artery (20) and into the aortic arch.

FIG. 2 is a schematic diagram of an external sheath system (30) advancedover the guidewire (10) until marker band (40) positioned on the sheathindicates the correct position, as determined by the manufacturer.

FIG. 3 is a schematic diagram of device (11) deployed to protect theleft subclavian, left common carotid, and brachiocephalic artery.

FIG. 4 is a schematic diagram of device (11) deployed to protect theleft subclavian, left common carotid, and brachiocephalic artery. Thedepicted device includes radiating supporting members (62).

FIG. 5A is a schematic diagram of device (11) wherein filter (50) ispre-attached to a delivery cable (60) (e.g., a NiTi tube), and thefilter (50) is positioned below the central member.

FIG. 5B is a schematic diagram of device (11) wherein a preformed bend(71) is present, filter (50) is pre-attached to a delivery cable (60)(e.g., a NiTi tube), and the filter is positioned above the centralmember.

FIG. 6 is a schematic diagram of device in an alternate configurationwherein the filter (50) is deployed to cover the right subclavian andbrachiocephalic artery while secondary filter (70) covers the leftsubclavian artery. Transition point (71) marks a post-deployment andpre-formed bend in delivery cable (e.g., 5°, 10°, 15°, 20°, 25°, 30°,35°, 40°, 45°, 50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, or 90°). Thedevice is depicted post deployment with external sheath (62) retracted.

FIG. 7A is a photograph of a cross section of DFT wire.

FIG. 7B is a schematic diagram of a filter mesh containing DFT wire.

FIG. 7C is a photograph of a radiopacity bead and clamp element for usein the invention.

FIG. 8A is a schematic diagram showing filter meshes of the indicatedpore sizes.

FIG. 8B is a schematic diagram showing perforated films with theindicated patterns, sizes, and densities of pores.

FIG. 8C is a schematic diagram showing a filter mesh with a combinationof DFT (Drawn Filled Tubing) and Nitinol wires.

FIGS. 9A-9C are photographs showing a variety of mechanisms forconnecting the device to a catheter or delivery cable.

FIG. 10 is a schematic diagram of a side view of a plunger for use inintroducing devices of the invention into a subject, e.g., through acatheter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention features an intravascular device for preventing particlesfrom passing from a primary blood vessel (e.g., the aorta) to one ormore secondary blood vessels (e.g., the left subclavian, left commoncarotid, and brachiocephalic artery). In general, the devices of theinvention feature a filter with an internal structure, including, e.g.,a central member. This internal structure provides, e.g., structure tothe filter and can, e.g., facilitate the control of the filter withinthe anatomy of the primary blood vessel. For example, this internalstructure (e.g., central member) can permit an operator to control theorientation of the device within the primary blood vessel and press thedevice against certain features of the primary blood vessel (e.g., topress the device against the orifice of one or more secondary bloodvessels or against the walls of the primary blood vessel). The devicesof the invention can also feature an outer skeleton connected to theinternal structure. The outer skeleton can provide additional structuralsupport for the device and can facilitate the creation of a seal betweenthe filter of the device and a blood vessel wall. Alternatively, thefilter itself may create a seal against the blood vessel wall byextending beyond the perimeter of the outer skeleton.

The device of the invention may include a filter, a central member,additional supporting members, and a delivery cable. The device canfilter and/or deflect emboli or other large objects from enteringprotected secondary vessels. The device may be capable of collapse alongits longitudinal axis for ease of delivery to the treatment site. Thedevice may further be compatible with common delivery methods used ininterventional cardiology (e.g., TAVI procedures). The device may beintegrated into a delivery system. In other embodiments the device maybe detachable from the delivery system. Upon deployment, the device maybe positioned so as to contact the orifice of one or more secondaryblood vessels in, e.g., the aortic arch. Upon retrieval the device maybe retracted in orientation substantially similar to the originaldeployment orientation.

Reference is made to FIG. 1 and FIG. 2: FIG. 1 is a schematic diagram ofa guide wire (10) passing through the left subclavian artery (20) intothe aortic vessel in the direction of the ascending aorta, and FIG. 2 isa schematic diagram of an external sheath system (30) is advanced overthe guidewire (10) until marker band (40) positioned on the sheathindicates the correct position, as determined by the manufacturer. Insome embodiments, the device (11) may be contracted when the device isfolded in an external sheath (30), and the filter area may expand whenthe filter is unfolded and deployed. Forward movement of outer tube willcollapse the device, while retrograde movement will allow deployment.The length of the device may be from approximately 80 mm to 90 mm (e.g.,80 mm, 82 mm, 84 mm, 86 mm, 88 mm, or 90 mm), or otherwise as may benecessary to approximate a distance between an upper wall of anascending aorta, upstream of an opening of a brachiocephalic artery, andat an upper wall of a descending aorta downstream of an opening of aleft subclavian artery. In some embodiments, the length of the devicemay be reduced to the length necessary to approximate a distance betweenthe upper wall of a descending aorta or an ascending aorta and theopening of the targeted artery (e.g., the left subclavian, left commoncarotid, or brachiocephalic artery). The width of the device may be from10 mm to 35 mm (e.g., 10 mm, 15 mm, 20 mm, 25 mm, 30 mm, or 35 mm), orotherwise as may approximate an internal diameter of an aorta or thediameter of a secondary blood vessel. The device may be inserted intothe aorta or introduced into a blood vessel in a collapsed form and mayassume an extended form upon its release from a sheath or otherinsertion or positioning mechanism.

Reference is made to FIG. 3 and FIG. 4: FIG. 3 is a schematic diagram ofan underside view of device (11) deployed in the aortic arch to protectall carotid branches (e.g., left subclavian (20), left common carotid(21), and brachiocephalic artery (22)), and FIG. 4 is a schematicdiagram of the deployed device (11) with additional members (62)extending from the central member (61). In some embodiments, it isdesirable to incorporate radiopaque elements into the intra-vasculardevice. Such radiopaque elements can be affixed to, or incorporated intothe intra-vascular device (e.g., affixed to the central member (61),filter (50), optional second filter (70, FIG. 6), or radiatingsupporting members (62)). The radiopaque element can be a bead or clamp(e.g., as depicted in FIG. 7C). In the case of a clamp, the element canbe crimped onto the intra-vascular device. In any of the embodiments ofthe invention, radiopaque material can be incorporated into wire formingthe central member (61), filters (50 or 70), or radiating supportingmembers (62) of the intra-vascular device (see, e.g., FIG. 7B). Forexample, portions of the central member or filter mesh can beconstructed out of DFT wire. Such wire can contain, e.g., a core oftantalum and/or platinum and an outer material of, e.g., Nitinol (see,e.g., FIG. 7A).

In some embodiments, filters (50 or 70) may be or include a fine wirenetting or mesh (e.g., as depicted in FIGS. 8A and 8C), or perforatedfilm (e.g., as depicted in FIG. 8B), such as a mesh or sheet havingholes or porosity of 50-950 microns (e.g., 50, 150, 250, 350, 450, 550,650, 750, 850, 950, or more microns). The perforated film may beperforated prior to the inclusion with the device. The film may also beperforated post inclusion with the device (e.g., by laser drilling orelectric sparks). In embodiments where a perforated film is present, thepores can have constant or varied pore patterns, constant or varied poredensities, and/or constant or varied pore sizes (FIG. 8B). The filters(50 or 70) may be braided, weaved, clustered, knitted, or knotted. Thefilters (50 or 70) may be a non-degradable material (e.g.,polycarbonate, polytetrafluorothylene (PTFE), expandedpolytetrafluorothylene (ePTFE), polyvinylidene fluoride, (PVDF),polypropylene, porous urethane, Nitinol, fluropolymers (Teflon®), cobaltchromium alloys (CoCr), and para-aramid (Kevlar®)), or textile (e.g.,nylon, polyester (Dacron®), or silk). The filter may be a combination ofmaterials (e.g., the combination of DFT and Nitinol wires as depicted inFIGS. 7A and 7B). The filters (50 or 70) may also be coated with ananti-thrombogenic agent to prevent a thrombogenic reaction.

In some embodiments, one or more members (61 or 62) or filters (50 or70) may include a lumen, such as, for example, a hollow wire, which mayhold, for example, a medicament that may be released into an artery orarea where the device is implanted. The central member can have, e.g., alength of 100%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 30%, 20%,10%, or less of the length of the longest region of the intra-vasculardevice. The radiating supporting members can have, e.g., a length of100%, 95%, 90%, 85%, 80%, 75%, 70%, 60%, 50%, 40%, 30%, 20%, 10%, orless of the width of the widest region of the intra-vascular device.

In some embodiments, device (11) may assume a substantially ellipticalor elongated shape. Other shapes may be used. Because the aortic anatomycan vary between individuals, embodiments of the intra-vascular deviceof the invention are shaped to adapt to a variety of aortic anatomies.The size of the device (11) may be pre-sized and pre-formed toaccommodate various patient groups (e.g., children and adults) orparticular aortic anatomy. The delivery cable (60) may be made from anon-degradable material (e.g., NiTi). The delivery cable (60) may alsobe pre-shaped to press against the top aortic wall lightly, thusallowing the device to remain along the vessel wall and clear of thepassage of trans-femoral accessories that may be used in therapeuticcardiovascular procedures (e.g., TAVI procedures). This pre-shape mayinclude a bend (71) (e.g., 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45°,50°, 55°, 60°, 65°, 70°, 75°, 80°, 85°, or 90°) to further facilitatedevice deployment flush to the a vessel wall. The device may vary inlength from 10 mm to 120 mm (e.g., 25 mm, 45 mm, 60 mm, 75 mm, 90 mm, or105 mm) and width from 5 mm to 70 mm (e.g., 10 mm, 20 mm, 30 mm, 40 mm,50 mm, or 60 mm).

In certain embodiments, the stiffness of the intra-vascular device willbe determined by the stiffness of the filter, central member, orradiating supporting members. For example, the device can be stiffenedby the inclusion of heavier gauge wire or by the inclusion of stiffercentral member or radiating supporting members. Furthermore, multiplewires of a certain gauge can be wound together to increase the stiffnessof the device (e.g., the device can include 2, 3, 4, 5, or more wires ofto increase the stiffness of the intra-vascular device).

Reference is made to FIGS. 5A and 5B: FIG. 5A is a schematic diagram ofdevice (11) with filter (50) positioned below the central member (61)and FIG. 5B is a schematic diagram of device (11) with filter (50)positioned above central member (61). In some embodiments, device (11)may include both a central member (61) and radiating supporting members(62) extending from central member. The filter (50) may also bepositioned either above or below these radiating supporting members. Insome embodiments, delivery cable (60) is integrated with filter (50) viaa connection between delivery cable (60) and central member (61). Theconnection between delivery cable (60) and central member (61) may beeither permanent (e.g., crimped, glued, soldered, or bonded) orsemi-permanent (e.g., clipped, latched, hooked, clamped, or screwed) toallow the detachment of filter (50) from delivery cable (61) afterdeployment.

Reference is made to FIG. 6, which is a schematic diagram of filter (50)positioned so that the opening of the brachiocephalic and left commoncarotid artery are covered by the filter. In some embodiments, the leftsubclavian artery is covered by a secondary filter (70). Secondaryfilter (70) may be attached to delivery cable (60). Secondary filter(70) may be conical in shape with the delivery cable (60) passingthrough the apex of the filter. The secondary filter (70) may also besubstantially flat with delivery cable (60) passing through any pointwithin secondary filter (70) so long as delivery cable (60) is connectedto filter (70), e.g., at all points along the delivery cable's outerperimeter. The width of the widest portion of secondary filter (70) maybe pre-sized and pre-formed to accommodate particular subclavianarterial anatomy (e.g, 2, 4, 6, or 8 mm in width) . Other shapes may beused.

Reference is made to FIGS. 9A-9C. As described above, a variety ofconfigurations can be used to connect the intra-vascular filter to aplunger (e.g., a plunger connected with a delivery cable disposed withina catheter). FIG. 9A depicts a locking mechanism with a latch. FIG. 9Bdepicts a screw whereby the intra-vascular device can be mated with ascrew on a plunger. FIG. 9C depicts a release and recapture hook forconnecting the intra-vascular device with a plunger. In someembodiments, a hook may include a latch or wire strand that may be partof the device.

In other embodiments, the filter (50), catheter, member (61), ordelivery cable (60) may end in a loop and may be threaded through alatch. When so threaded, a wire or catheter fitted with a looped end maybe clicked into a hook and may securely push the device into place orpull the device out of position from a blood vessel (e.g., the aorta).

In some embodiments, the hook may end in a ball-tip so that strands fromthe filter (50) do not fray or scratch the vessel wall or the inner tubeof a catheter.

In other embodiments, a clasp at an end of the device may be pressedinto or onto a clasp at, for example, an end of a catheter or deliverycable (60), and the two clasps may be joined by such pressing. In someembodiments, the device may be rotated clockwise or counter-clockwiserespectively.

In an installed position, the intra-vascular device may be inserted intoa first blood vessel. In some embodiments, the first blood vessel may beor include an aorta, though the device may be inserted into othervessels. The filter (50) of the device may be positioned so that anopening of a second blood vessel is covered by the filter, so that, forexample, large particles are filtered, blocked, or deflected fromentering, for example, the left subclavian, left common carotid, orbrachiocephalic artery, or any combination thereof (e.g., the leftsubclavian, left common carotid, and brachiocephalic artery; the leftsubclavian and left common carotid artery; left common carotid andbrachiocephalic artery; and the left common carotid and brachiocephalicartery). The space under filter (50) may allow unfiltered blood to passby the branch artery of the aorta. The space in the aorta that is leftbelow the filter means that not all blood passing through the aorta issubject to the filtering or deflecting process of filter (30). In aninstalled position, the device remains substantially flat (e.g., doesnot exceed a radius of curvature of 80 mm).

Reference is made to FIG. 10. A shaft or plunger for use in connectionwith the device can terminate in a loop (as depicted in FIG. 10) or ascrew. In embodiments where a loop is present, the loop can be generatedby winding two wires together leaving a loop at the distal end (FIG.10). The shaft or plunger can, e.g., include a radiopaque element.Furthermore, the shaft or plunger can feature a rectilinear (e.g.,square) or curved (e.g., oval or circular) cross section. Differences incross sectional shape can have advantageous properties with respect tocontrolling the positioning of the intra-vascular device within theaorta. In certain embodiments, a shaft or plunger may replace or be usedin conjunction with delivery cable (61).

In still other embodiments, device (11) may be adapted for use withother embolism protection devices (e.g., those described U.S.application Ser. Nos. 13/300,936, and 13/205,255; in U.S. PublicationNos. 2008-0255603 and 2011-0106137; and in U.S. Pat. Nos. 8,062,324 and7,232,453), each of which is hereby incorporated by reference in itsentirety.

All publications and patents cited in this specification areincorporated herein by reference as if each individual publication orpatent were specifically and individually indicated to be incorporatedby reference. Although the foregoing invention has been described insome detail by way of illustration and example for purposes of clarityof understanding, it will be readily apparent to those of ordinary skillin the art in light of the teachings of this invention that certainchanges and modifications may be made thereto without departing from thespirit or scope of the appended claims.

What is claimed is:
 1. An intra-vascular device comprising; (i) asubstantially planar filter; and (ii) a central member connected to saidfilter, wherein, when said device is deployed in a primary blood vesselhaving one or more secondary blood vessels: a. a portion of said centralmember extends from a horizontal plane of said filter into a first ofsaid one or more secondary blood vessels; b. said device is configuredsuch that said central member partially obstructs at least one of saidone or more secondary blood vessels; and c. said device is capable ofcollapse along a longitudinal axis.
 2. The device as in claim 1, whereinsaid central member is hollow.
 3. The device as in claim 1, wherein saidcentral member provides structural support.
 4. The device as in claim 2,wherein said hollow central member permits the passage of a guidewire.5. The device as in claim 1, wherein said device further comprises oneor more additional members extending outwards from the central member.6. The device as in claim 5, wherein said one or more additional membersprovide structural support. 7-8. (canceled)
 9. The device as in claim 5,wherein said one or more additional members comprise NiTi. 10.(canceled)
 11. The device as in claim 1, wherein said filter comprisesbraided, woven, or clustered material.
 12. The device as in claim 1,wherein said filter comprises Nitinol mesh.
 13. The device as in claim1, wherein said filter comprises perforated film.
 14. (canceled)
 15. Thedevice as in claim 12, wherein said mesh is laminated. 16-17. (canceled)18. The device as in claim 1, wherein said substantially planar filteris adapted to conform to the vessel wall.
 19. The device as in claim 1,further comprising an outer skeleton around said filter.
 20. The deviceas in claim 19, wherein said outer skeleton defines the edge of thesubstantially planar filter.
 21. The device as in claim 19, wherein thesubstantially planar filter extends beyond the outer skeleton, allowingthe filter to conform to the wall of said primary blood vessel. 22-28.(canceled)
 29. The device as in claim 1, wherein said device furthercomprises a radiopacity marker.
 30. The device as in claim 29, whereinsaid radiopacity marker is a bead or a clamp.
 31. The device as in claim5, wherein said one or more additional members are located above thefilter.
 32. The device as in claim 5, wherein said one or moreadditional members are located below the filter.
 33. The device as inclaim 1, wherein said central member further comprises a preformed bendproximal to said filter.
 34. (canceled)
 35. The device as in claim 33,wherein said device further comprises (iii) a second filter attached tosaid central member portion proximal to the substantially planar filterand a preformed bend; and wherein said second filter is sized to filtersaid first of said one or more secondary blood vessels.
 36. The deviceas in claim 35, wherein said central member passes through said secondfilter.
 37. (canceled)
 38. The device as in claim 1, wherein saidsubstantially planar filter has a length to width ratio between 8:1 and18:7.
 39. The device as in claim 1, wherein said central member isconnected to a delivery cable. 40-41. (canceled)
 42. A method ofpreventing passage of a particle from the aorta into the leftsubclavian, left common carotid, or brachiocephalic artery comprisingdeploying the device of claim 1 in said aorta such that said deviceprevents particles from passing to the left subclavian, left commoncarotid, or brachiocephalic artery.
 43. (canceled)
 44. A method ofpreventing passage of a particle from the aorta into the leftsubclavian, left common carotid, or brachiocephalic artery comprisingdeploying the device of claim 1 in said aorta such that: a. said deviceprevents particles from passing to the left subclavian, left commoncarotid, or brachiocephalic artery; and b. said device may be retrievedin an orientation substantially similar to the deployment orientation.45-48. (canceled)
 49. A method of preventing passage of a particle fromthe aorta into the left subclavian, left common carotid, orbrachiocephalic artery comprising: inserting a guidewire through one ofthe left subclavian, left common carotid, or brachiocephalic artery andinto the aortic arch; passing a catheter containing the device of claim1 in collapsed form over the guidewire and into said aortic arch; andretracting said catheter so that said device is deployed in said aorticarch, thereby preventing passage of a particle from the aorta into theleft subclavian, left common carotid, or brachiocephalic artery. 50-53.(canceled)